Dietary supplements are vitamins, minerals, herbs, and many other products. They can come as pills, capsules, powders, drinks, and energy bars. Supplements do not have to go through the testing that drugs do.

Some supplements can play an important role in health. For example, calcium and vitamin D are important for keeping bones strong. Pregnant women can take the vitamin folic acid to prevent certain birth defects in their babies.

To take a supplement as safely as possible:

• Tell your health care provider about any dietary supplements you use
• Do not take a bigger dose than the label recommends
• Check with your health care provider about the supplements you take if you are going to have any type of surgery
• Read trustworthy information about the supplement

Multivitamins, vitamin D, echinacea, and fish oil are among the many dietary supplements lining store shelves or available online. Perhaps you already take a supplement or are thinking about using one. Dietary supplements can be beneficial to your health, but they can also involve health risks. So, it’s important that you talk with a health care professional to help you decide if a supplement is right for you.

Read on to learn what dietary supplements are (and are not), what role the U.S. Food and Drug Administration has in regulating them, and how to make sure you and your family use supplements safely.

What Are Dietary Supplements?

Dietary supplements are intended to add to or supplement the diet and are different from conventional food. Generally, to the extent a product is intended to treat, diagnose, cure, or prevent diseases, it is a drug, even if it is labeled as a dietary supplement. Supplements are ingested and come in many forms, including tablets, capsules, soft gels, gel caps, powders, bars, gummies, and liquids.

Common supplements include:

• Vitamins (such as multivitamins or individual vitamins like vitamin D and biotin).
• Minerals (such as calcium, magnesium, and iron).
• Botanicals or herbs (such as echinacea and ginger).
• Botanical compounds (such as caffeine and curcumin).
• Amino acids (such as tryptophan and glutamine).
• Live microbials (commonly referred to as “probiotics”).

What Are the Benefits of Dietary Supplements?

Dietary supplements can help you improve or maintain your overall health, and supplements can also help you meet your daily requirements of essential nutrients.

For example, calcium and vitamin D can help build strong bones, and fiber can help to maintain bowel regularity. While the benefits of some supplements are well established, other supplements need more study. Also, keep in mind that supplements should not take the place of the variety of foods that are important for a healthy diet.

What Are the Risks of Dietary Supplements?

Before buying or taking a dietary supplement, talk with a health care professional—such as your doctor, nurse, registered dietician, or pharmacist—about the benefits and risks.

Many supplements contain ingredients that can have strong effects in the body. Additionally, some supplements can interact with medications, interfere with lab tests, or have dangerous effects during surgery. Your health care professional can help you decide what supplement, if any, is right for you.

When taking dietary supplements, be alert to the possibility of a bad reaction or side effect (also known as an adverse event).

Problems can occur especially if you:

• Combine supplements.
• Mix medicines and supplements.
• Take too much of some supplements.
• Take supplements instead of medications.

How Are Dietary Supplements Regulated?

The Law

The Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended in 1994 by the Dietary Supplement Health and Education Act (often referred to as DSHEA), which defined “dietary supplement” and set out FDA’s authority regarding such products. Under existing law:

• The FDA does NOT have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public.
• Under the FD&C Act, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law.
• Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. They also must have a statement on the front of the product identifying it as a “dietary supplement” or similar descriptive term (e.g., “herbal supplement” or “calcium supplement”). 

In general, even if a product is labeled as a dietary supplement, a product intended to treat, prevent, cure, or alleviate the symptoms of a disease is a drug, and subject to all requirements that apply to drugs.

The FDA’s Role and Actions to Help Keep You Safe

Even though the FDA does not approve dietary supplements, there are roles for the agency in regulating them.

• Since companies can often introduce a dietary supplement to the market without notifying the FDA, the agency's role in regulating supplements primarily begins after the product enters the marketplace.
• The FDA periodically inspects dietary supplement manufacturing facilities to verify companies are meeting applicable manufacturing and labeling requirements.
• The FDA also reviews product labels and other labeling information, including websites, to ensure products are appropriately labeled and that they do not include claims that may render the products drugs (e.g., claims to treat, diagnose, cure, or prevent diseases).
• The FDA monitors adverse event reports submitted by dietary supplement companies, health care professionals, and consumers as well as other product complaints for valuable information about the safety of products once they are on the market.
• If a product is found to be unsafe or doesn’t otherwise comply with the law, the FDA can:
  • Work with the company to bring the product into compliance.
  • Ask the company to voluntarily recall the product.
  • Take action to remove a dangerous product from the market.

Tips to Be a Safe and Informed Consumer

Before taking a dietary supplement, talk with your health care professional. They can help you decide which supplements, if any, are right for you. You can also contact the manufacturer for information about the product.

• Take only as described on the label. Some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain drugs or foods.
• Do not substitute a dietary supplement for a prescription medicine or for the variety of foods important to a healthy diet.
• Do not assume that the term "natural" to describe a product ensures that it is safe.
• Be wary of hype. Sound health advice is generally based upon research over time, not a single study.
• Learn to spot false claims. If something sounds too good to be true, it probably is.

Why Is It Important to Report an Adverse Event?

If you experience adverse event, also known as a side effect or bad reaction, the FDA encourages both you and your health care professional to report the adverse event to the FDA.

You can help the FDA, yourself, and other consumers by reporting an adverse event. A single adverse event report can help us identify a potentially dangerous product and possibly remove it from the market.

Adverse events can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to report serious adverse events they receive about their dietary supplements to FDA within 15 days.

Many adults and children in the United States take one or more vitamins or other dietary supplements. In addition to vitamins, dietary supplements can contain minerals, herbs or other botanicals, amino acids, enzymes, and many other ingredients. Dietary supplements come in a variety of forms, including tablets, capsules, gummies, and powders, as well as drinks and energy bars. Popular supplements include vitamins D and B12; minerals like calcium and iron; herbs such as echinacea and garlic; and products like glucosamine, probiotics, and fish oils.

The Dietary Supplement Label

Products sold as dietary supplements come with a Supplement Facts label that lists the active ingredients, the amount per serving (dose), as well as other ingredients, such as fillers, binders, and flavorings. The manufacturer suggests the serving size, but your healthcare provider might decide a different amount is more appropriate for you.

Effectiveness

Some dietary supplements can help you get adequate amounts of essential nutrients if you don’t eat a nutritious variety of foods. However, supplements can’t take the place of the variety of foods that are important to a healthy eating routine. To learn more about what makes a healthy eating routine, the Dietary Guidelines for Americans and MyPlate are good sources of information.

Some dietary supplements can improve overall health and help manage some health conditions. For example: 

• Calcium and vitamin D help keep bones strong and reduce bone loss. 
• Folic acid decreases the risk of certain birth defects.
• Omega-3 fatty acids from fish oils might help some people with heart disease. 
• A combination of vitamins C and E, zinc, copper, lutein, and zeaxanthin (known as an AREDS formula) may slow down further vision loss in people with age-related macular degeneration (AMD). 

Many other supplements need more study to determine if they have value. The U.S. Food and Drug Administration (FDA) does not determine whether dietary supplements are effective before they are marketed.

Safety and Risk

Many supplements contain active ingredients that can have strong effects in the body. Always be alert to the possibility of a bad reaction, especially when taking a new product.

You are most likely to have side effects from dietary supplements if you take them at high doses or instead of prescribed medicines, or if you take many different supplements. Some supplements can increase the risk of bleeding or, if taken before surgery, can change your response to anesthesia. Supplements can also interact with some medicines in ways that might cause problems. Here are a few examples:

• Vitamin K can reduce the ability of the blood thinner warfarin to prevent blood from clotting.
• St. John’s wort can speed the breakdown of many medicines and reduce their effectiveness (including some antidepressants, birth control pills, heart medications, anti-HIV medications, and transplant drugs).
• Antioxidant supplements, such as vitamins C and E, might reduce the effectiveness of some types of cancer chemotherapy.

Manufacturers may add vitamins, minerals, and other supplement ingredients to foods you eat, especially breakfast cereals and beverages. As a result, you may get more of these ingredients than you think, and more might not be better. Taking more than you need costs more and might also raise your risk of side effects. For example, too much vitamin A can cause headaches and liver damage, reduce bone strength, and cause birth defects. Excess iron causes nausea and vomiting and may damage the liver and other organs.

Be cautious about taking dietary supplements, beyond a standard prenatal supplement, if you are pregnant or nursing. Also, be careful about giving supplements to a child, unless recommended by their health care provider. Many supplements have not been well tested for safety in children and in those who are pregnant or nursing.

If you think that you have had a bad reaction to a dietary supplement, let your health care provider know. They may report your experience to the FDA. You may also submit a report directly to the FDA by calling 800-FDA-1088 or completing an online form. You should also report your reaction to the manufacturer by using the contact information on the product label.

Quality

The FDA has established good manufacturing practices (GMPs) that companies must follow to help ensure the identity, purity, strength, and composition of their dietary supplements. These GMPs can prevent adding the wrong ingredient (or too much or too little of the correct ingredient) and reduce the chance of contamination or improper packaging and labeling of a product. The FDA periodically inspects facilities that manufacture supplements.

Several independent organizations offer quality testing and allow products that pass these tests to display a seal of quality assurance that indicates the product was properly manufactured, contains the ingredients listed on the label, and does not contain harmful levels of contaminants. These seals do not guarantee that a product is safe or effective. Organizations that offer quality testing include:*

• ConsumerLab.com
• NSF International
• U.S. Pharmacopeia

* Any mention of a specific company, organization, or service does not represent an endorsement by ODS.

Talk with Your Healthcare Providers

Tell your healthcare providers (including doctors, dentists, pharmacists, and dietitians) about any dietary supplements you’re taking. They can help you determine which supplements, if any, might be valuable for you.

Keep a complete record of any dietary supplements and medicines you take. The Office of Dietary Supplements website has a useful form, ”My Dietary Supplement and Medicine Record,” that you can print and fill out at home. For each product, note the name, the dose you take, how often you take it, and the reason for use. You can share this record with your healthcare providers to discuss what’s best for your overall health.

Keep in Mind

• Consult your healthcare provider before taking dietary supplements to treat a health condition.
• Get your healthcare provider’s approval before taking dietary supplements in place of, or in combination with, prescribed medicines.
• If you are scheduled to have any type of surgical procedure, talk with your healthcare provider about any supplements you take.
• Keep in mind the term “natural” doesn’t always mean safe. Some all-natural botanical products, for example, like comfrey and kava, can harm the liver. A dietary supplement’s safety depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the amount you take.
• Before taking any dietary supplement, use the information sources listed in this brochure and talk to your healthcare providers to answer these questions:
  • What are its potential benefits for me?
  • Does it have any safety risks?
  • What is the proper dose to take?
  • How, when, and for how long should I take it?

Federal Regulation of Dietary Supplements

Dietary supplements are products intended to supplement the diet. They are not medicines and are not intended to treat, diagnose, mitigate, prevent, or cure diseases. The FDA is the federal agency that oversees both supplements and medicines, but the FDA regulations for dietary supplements are different from those for prescription or over-the-counter medicines.

Medicines must be approved by the FDA before they can be sold or marketed. Supplements do not require this approval. Supplement companies are responsible for having evidence that their products are safe, and the label claims are truthful and not misleading. However, as long as the product does not contain a “new dietary ingredient” (one introduced since October 15, 1994), the company does not have to provide this safety evidence to the FDA before the product is marketed.

Dietary supplement labels may include certain types of health-related claims. Manufacturers are permitted to say, for example, that a supplement promotes health or supports a body part or function (like heart health or the immune system). These claims must be followed by the words, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Manufacturers must follow good manufacturing practices (GMPs) to ensure the identity, purity, strength, and composition of their products. If the FDA finds a dietary supplement to be unsafe, it may remove the product from the marketplace or ask the manufacturer to voluntarily recall the product.

The FDA monitors the marketplace for potential illegal products that may be unsafe or make false or misleading claims. The Federal Trade Commission, which monitors product advertising, also requires information about a supplement product to be truthful and not misleading.

The federal government can take legal action against companies and websites that sell dietary supplements when the companies make false or deceptive statements about their products, if they promote them as treatments or cures for diseases, or if their products are unsafe.

Bottles of supplements line the shelves at your local supermarket. These include vitamins and minerals from A to zinc. You can also find products like probiotics, herbs, and fish oil. But are they needed for good health? And what about their risks?

“For most people, eating a nutritious variety of foods can provide all the nutrients they need,” says Carol Haggans, a registered dietitian and consultant with NIH. But some may need more than they get from their meals. Your needs can vary depending on your age, health, and what you eat.

Many misunderstand what dietary supplements are for, Haggans explains. “Some people might believe or hope that supplements can prevent or treat disease, but that’s not what they’re intended to do,” she says. “They’re intended to supplement the diet.”

Dietary supplements are regulated by the U.S. Food and Drug Administration. “But they’re regulated under the umbrella of food,” says Haggans. “It’s important for people to know that they’re not regulated like medicines.”

That means companies don’t have to prove that a supplement works before selling it. Companies are required to follow good manufacturing practices in making their products. But bottles still may not always contain what the label claims.

A few independent organizations conduct quality tests of supplements and give seals of approval. But these tests only ensure that a product was properly made and contains the listed ingredients. They don’t guarantee that it works or is safe to take.

Who Needs Supplements?

Your body needs different amounts of certain nutrients at different times in your life. For example, the ability to absorb and process some nutrients decreases with age. So older adults may need more of certain vitamins and minerals, such as vitamin D, vitamin B12, and calcium.

People who avoid certain foods may also need a nutrient boost. For example, vitamin B12 is found only in animal products. “So if you follow a vegan diet, you may not get enough B12 from food,” Haggans says.

Women who are pregnant, or may become pregnant, need a certain amount of folic acid. This helps prevent a type of birth defect called neural tube defects. And infants may need more vitamin D than the amount found in breast milk.

People with chronic health conditions also may need more of some vitamins and minerals, says Dr. Patricia Haggerty, who studies nutrition and the immune system at NIH. These conditions include heart disease, diabetes, cancer, HIV/AIDS, and some autoimmune diseases .

But whether you need a supplement—and which one or ones—isn’t something to guess at, Haggerty says. “Which supplements, the dosage, and so on, are things you should work out with your health care provider.” Blood tests often can help determine whether you have a nutrient deficiency.

Safety Concerns

If you take supplements, tell your health care providers. Some supplements can change how well medications work. Others have risks for specific groups of people.

“It’s also important to know the total amount of nutrients you’re getting from both food and different supplements,” Haggans says. “More is not necessarily better, and natural doesn’t necessarily mean safe.”

Many nutrients can be dangerous in large amounts. These have what’s called an upper intake level. Regularly getting more than that level can lead to serious health problems. Vitamins and minerals with an upper limit include calcium, iron, zinc, and vitamins A, B6, C, and D.

Manufacturers aren’t required to keep their products below these upper limits, Haggans explains. So check the labels before you buy. And some nutrients, like vitamin K, can interact with common medications.

Other types of dietary supplements, such as botanicals, can be even more complicated. Botanicals are also known as herbal supplements. They contain one or more parts of a plant. Examples include ginseng, echinacea, and St. John’s wort. Botanicals can come in many forms, such as capsules, dried teas, or liquid preparations.

Botanical products can vary in their ingredients from brand to brand. So their effects in the body can vary. “They can also interact with medications and have side effects,” says Haggans.

Some botanical products may come with health claims that go too far, says Dr. Ikhlas Khan, an NIH-funded natural products researcher at the University of Mississippi. Examples include helping you “sleep better” or “lose weight.”

“If you’re looking for a cure, you shouldn’t be looking in the supplement aisle,” he says.

Boosting Your Immune System

Perhaps the most common claim for supplements is that they boost your immune system. Researchers have been studying whether any can help.

“Many nutrients, like vitamin C, vitamin D, vitamin E, zinc, selenium, and magnesium are important for a healthy immune system,” Haggerty says. But so far, getting more than the recommended amount of any nutrient doesn’t appear to boost the immune system.

Researchers are testing whether certain supplements can lessen COVID-19 symptoms. “But so far, the data are insufficient to support recommendations for or against any vitamin, mineral, or botanical product to prevent or treat COVID-19,” Haggerty says.

Scientists are also looking at supplements for other viruses. Khan and colleagues are studying a botanical extract made from a type of algae, called spirulina. Studies in mice have shown that compounds in it may increase the immune response and protect against viral infection. The team wants to test whether it can be used to protect against the flu.

But a challenge with botanical supplements is that they can vary from bottle to bottle, Khan explains. So the team must first fully characterize the product before they can test it in clinical trials.

You might wonder: If supplements aren’t the answer, what can you do to boost your immune system right now? “The most important thing is to eat a nutritious variety of foods and maintain a healthy weight,” Haggerty says. Obesity can weaken your immune system.

It’s also important to get regular physical activity, enough sleep, and to minimize stress. Don’t smoke. If you drink alcohol, do so in moderation. Keep up with your vaccines. And wash your hands to lower your chances of getting sick.

“These are all things we can do on a daily basis to keep our immune system healthy,” Haggerty says.

Before taking a supplement, ask:

• Can this supplement help with my health concern? If so, how much should I take?
• Does this supplement have any harms associated with it? What side effects should I look for?
• Could this supplement interact with my prescription medications? What about over-the-counter medications?
• How do I know whether a supplement contains what it says it does? Can you recommend a brand to take?

When you reach for that bottle of vitamin C or fish oil pills, you might wonder how well they’ll work and if they’re safe. The first thing to ask yourself is whether you need them in the first place.

More than half of all Americans take one or more dietary supplements daily or on occasion. Supplements are available without a prescription and usually come in pill, powder or liquid form. Common supplements include vitamins, minerals and herbal products, also known as botanicals.

People take these supplements to make sure they get enough essential nutrients and to maintain or improve their health. But not everyone needs to take supplements.

“It’s possible to get all of the nutrients you need by eating a variety of healthy foods, so you don’t have to take one,” says Carol Haggans, a registered dietitian and consultant to NIH. “But supplements can be useful for filling in gaps in your diet.”

Some supplements may have side effects, especially if taken before surgery or with other medicines. Supplements can also cause problems if you have certain health conditions. And the effects of many supplements haven’t been tested in children, pregnant women and other groups. So talk with your health care provider if you’re thinking about taking dietary supplements.

“You should discuss with your doctor what supplements you’re taking so your care can be integrated and managed,” advises Dr. Craig Hopp, an expert in botanicals research at NIH.

Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods, not as drugs. The label may claim certain health benefits. But unlike medicines, supplements can’t claim to cure, treat or prevent a disease.

“There’s little evidence that any supplement can reverse the course of any chronic disease,” says Hopp. “Don’t take supplements with that expectation.”

Evidence does suggest that some supplements can enhance health in different ways. The most popular nutrient supplements are multivitamins, calcium and vitamins B, C and D. Calcium supports bone health, and vitamin D helps the body absorb calcium. Vitamins C and E are antioxidants—molecules that prevent cell damage and help to maintain health.

Women need iron during pregnancy, and breastfed infants need vitamin D. Folic acid—400 micrograms daily, whether from supplements or fortified food—is important for all women of childbearing age.

Vitamin B12 keeps nerve and blood cells healthy. “Vitamin B12 mostly comes from meat, fish and dairy foods, so vegans may consider taking a supplement to be sure to get enough of it,” Haggans says.

Research suggests that fish oil can promote heart health. Of the supplements not derived from vitamins and minerals, Hopp says, “fish oil probably has the most scientific evidence to support its use.”

The health effects of some other common supplements need more study. These include glucosamine (for joint pain) and herbal supplements such as echinacea (immune health) and flaxseed oil (digestion).

Many supplements have mild effects with few risks. But use caution. Vitamin K, for example, will reduce the ability of blood thinners to work. Ginkgo can increase blood thinning. The herb St. John’s wort is sometimes used to ease depression, anxiety or nerve pain, but it can also speed the breakdown of many drugs—such as antidepressants and birth control pills—and make them less effective.

Just because a supplement is promoted as “natural” doesn’t necessarily mean it’s safe. The herbs comfrey and kava, for example, can seriously damage the liver.

“It’s important to know the chemical makeup, how it’s prepared, and how it works in the body—especially for herbs, but also for nutrients,” says Haggans. “Talk to a health care provider for advice on whether you need a supplement in the first place, the dose and possible interactions with medicine you’re already taking.”

For vitamins and minerals, check the % Daily Value (DV) for each nutrient to make sure you’re not getting too much. “It’s important to consider the DV and upper limit,” says Haggans. Too much of certain supplements can be harmful.

Scientists still have much to learn even about common vitamins. One recent study found unexpected evidence about vitamin E. Earlier research suggested that men who took vitamin E supplements might have a lower risk of developing prostate cancer. “But much to our surprise, a large NIH-funded clinical trial of more than 29,000 men found that taking supplements of vitamin E actually raised—not reduced—their risk of this disease,” says Dr. Paul M. Coates, director of NIH’s Office of Dietary Supplements. That’s why it’s important to conduct clinical studies of supplements to confirm their effects.

Because supplements are regulated as foods, not as drugs, the FDA doesn’t evaluate the quality of supplements or assess their effects on the body. If a product is found to be unsafe after it reaches the market, the FDA can restrict or ban its use.

Manufacturers are also responsible for the product’s purity, and they must accurately list ingredients and their amounts. But there’s no regulatory agency that makes sure that labels match what’s in the bottles. You risk getting less, or sometimes more, of the listed ingredients. All of the ingredients may not even be listed.

A few independent organizations conduct quality tests of supplements and offer seals of approval. This doesn’t guarantee the product works or is safe; it just assures the product was properly made and contains the listed ingredients.

“Products sold nationally in the stores and online where you usually shop should be fine,” Coates says. “According to the FDA, supplement products most likely to be contaminated with pharmaceutical ingredients are herbal remedies promoted for weight loss and for sexual or athletic performance enhancement.”

To make it easy to find reliable information, NIH has fact sheets on dietary supplements at ods.od.nih.gov/factsheets/list-all/. NIH also recently launched an online Dietary Supplement Label Database at www.dsld.nlm.nih.gov. This free database lets you look up the ingredients of thousands of dietary supplements. It includes information from the label on dosage, health claims and cautions.

For more personalized, on-the-go information about dietary supplements, check out NIH’s free updated app for your smart phone or tablet: My Dietary Supplements (MyDS).

The MyDS app provides the latest supplement information and lets you keep track of the vitamins, minerals, herbs and other products you take. You can even keep track of supplements taken by your parents, spouse or children.

“Deciding whether to take dietary supplements and which ones to take is a serious matter,” says Coates. “Learn about their potential benefits and any risks they may pose first. Speak to your health care providers about products of interest and decide together what might be best for you to take, if anything, for your overall health.”

Safe Use of Supplements

• Tell all of your health care providers about any dietary supplements you use. Some supplements can interact with medications or affect medical conditions.
• Read the label instructions for use.
• “Natural” doesn’t always mean safe. For up-to-date news about the safety of particular supplements, check nccam.nih.gov/news/alerts.
• Too much might be harmful. Don’t take more than the recommended dose.

What’s the Bottom Line?

How much do we know about dietary supplements?

The amount of scientific evidence we have on dietary supplements varies widely—we have a lot of information on some and very little on others.

What do we know about the effectiveness of dietary supplements?

• Studies have found that some dietary supplements may have some benefit, such as melatonin for jet lag, and others may have little or no benefit, such as ginkgo for dementia.
• Supplements you buy from stores or online may differ in important ways from products tested in studies.
• Most research shows that taking multivitamins doesn’t result in living longer, slowing cognitive decline, or lowering the chance of getting cancer, heart disease, or diabetes.

What do we know about the safety of dietary supplements?

• Taking a multivitamin is unlikely to pose any health risks.
• Dietary supplements may interact with your medications or pose risks if you have certain medical problems or are going to have surgery.
• Many dietary supplements haven’t been tested in pregnant women, nursing mothers, or children.
• Some products marketed as dietary supplements—promoted mainly for weight loss, sexual enhancement, and bodybuilding—may contain prescription drugs not allowed in dietary supplements or other ingredients not listed on the label. Some of these ingredients may be unsafe.

What Are Dietary Supplements?

Federal law defines dietary supplements as products that:

• You take by mouth (such as a tablet, capsule, powder, or liquid)
• Are made to supplement the diet
• Have one or more dietary ingredients, including vitamins, minerals, herbs or other botanicals, amino acids, enzymes, tissues from organs or glands, or extracts of these
• Are labeled as being dietary supplements.

What Are Herbal Supplements?

Herbal supplements are a type of dietary supplement containing one or more herbs. They are:

• Sometimes called botanicals
• Made from plants, algae, fungi, or a combination of these
• Sold as teas, extracts, tablets, capsules, powders, or in other forms.

Dietary Supplement Use in the United States

According to the 2012 National Health Interview Survey, which included questions on Americans’ use of natural products (dietary supplements other than vitamins and minerals), almost 18 percent of adults and about 5 percent of children used these products in 2012.

More

• The National Health and Nutrition Examination Survey collected data from 2011 to 2012 on the use of all types of dietary supplements. It found that 52 percent of American adults took at least one dietary supplement. Multivitamin or multimineral supplements—a product having 10 or more vitamins or minerals—were one of the most common, and 31 percent of all adults took them. This was a decrease from 1999 to 2000, when 37 percent of American adults reported using multivitamin or multimineral supplements. Women were more likely than men to take dietary supplements.

Why Do People Use Dietary Supplements?

American adults often use dietary supplements for wellness. According to the 2012 National Health Interview Survey, 89 percent of American adults who took dietary supplements other than vitamins and minerals gave wellness-related reasons for using them, including:

• General wellness or disease prevention (83 percent)
• Improve immune function (42 percent)
• Improve energy (31 percent)
• Focuses on the whole person—mind, body, and spirit (27 percent)
• Improve memory or concentration (22 percent).

Federal Regulation of Dietary Supplements

• Federal regulations state that companies are responsible for having evidence that their dietary supplements are safe and for ensuring that product labels are truthful and not misleading. Manufacturers are required to produce dietary supplements in a quality manner, ensure that they don’t contain contaminants or impurities, and label them accurately.
• However, rules for manufacturing and distributing dietary supplements are less strict than those for prescription or over-the-counter drugs.
  • The U.S. Food and Drug Administration (FDA), which regulates dietary supplements, requires that companies submit safety data about any new ingredient not sold in the United States in a dietary supplement before 1994. In all other cases, the FDA is not authorized to review dietary supplements for safety and effectiveness before they are marketed.
  • The FDA can take action against adulterated or misbranded dietary supplements only after the product is on the market. In contrast, companies must show the FDA evidence that their prescription and over-the-counter drugs are safe and effective before the drugs are marketed.
• Once a dietary supplement is on the market, the FDA tracks side effects reported by consumers, supplement companies, and others. 
• If the FDA finds a product to be unsafe, it can take legal action against the manufacturer or distributor, and may issue a warning or require that the product be removed from the marketplace. However, the FDA says it can’t test all products marketed as dietary supplements that may have potentially harmful hidden ingredients. In 2023, the FDA launched the Dietary Supplement Ingredient Directory, a webpage where the public can look up ingredients used in products marketed as dietary supplements and find what the FDA has said about that ingredient, as well as whether the agency has taken any action with regard to the ingredient.

Health and Structure/Function Claims

• The labels on dietary supplements cannot claim that the product can diagnose, treat, cure, mitigate, or prevent any disease; claims like these are only permitted for drugs. However, some types of claims related to health or the way that the product affects the structure or function of the body may appear on dietary supplement labels.
  • Health claims describe a relationship between a substance in the supplement and reduced risk of a disease or condition. They must be based on scientific evidence. For example, if a supplement label says “Calcium may reduce the risk of the bone disease osteoporosis,” that’s a health claim.
  • Structure/function claims describe the effect of a substance on maintaining the body’s normal structure or function. For example, if a supplement label says “Calcium builds strong bones,” that’s a structure/function claim. Structure/function claims on dietary supplement labels must be accompanied by this disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, mitigate, or prevent any disease.”
  • Advertising
    The U.S. Federal Trade Commission (FTC), which regulates advertising, requires that advertising be truthful and not misleading.

What the Science Says About the Effectiveness of Dietary Supplements

• Some dietary supplements can be good for your health, while others haven’t been proven to work. 
• Studies of some supplements haven’t supported claims made about them. For example, in several studies, echinacea didn’t help cure colds and Ginkgo biloba wasn’t useful for dementia. Many times the research on a dietary supplement is conflicting, such as whether the supplements glucosamine and chondroitin improve symptoms of osteoarthritis.

• Strong evidence to back up claims made for dietary supplements is often lacking. For example, a 2022 review identified 27 ingredients frequently included in supplements with claims related to immune function, such as “supports healthy immune system” or “natural immune booster.” The reviewers searched the scientific literature for rigorous studies in people on the effectiveness of each ingredient, and they found evidence of this type for only eight of them. Some of the studies suggested possible benefits, but the evidence wasn’t strong enough to allow definite conclusions to be reached. Additional research is needed so consumers will know whether a dietary supplement promoted for immune health can help protect them from getting sick.

What the Science Says About the Safety and Side Effects of Dietary Supplements

• What’s on the label may not be what’s in the product. For example, the FDA has found prescription drugs, including anticoagulants (e.g., warfarin), anticonvulsants (e.g., phenytoin), and others, in products being sold as dietary supplements. 
• A 2012 Government study of 127 dietary supplements marketed for weight loss or to support the immune system found that 20 percent made illegal claims.
• Some dietary supplements may harm you if you have a particular medical condition or risk factor or are taking certain prescription or over-the-counter medications. For example, the herbal supplement St. John’s wort makes many medications less effective.
• Dietary supplements result in an estimated 23,000 emergency room visits every year in the United States, according to a 2015 study. Many of the patients are young adults having heart problems from weight-loss or energy products and older adults having swallowing problems from taking large vitamin pills.
• Although it’s still rare, more cases are being reported of acute (sudden) liver damage in people taking dietary supplements in the United States and elsewhere. The liver injury can be severe, can require an emergency liver transplant, and is sometimes fatal.
• Many dietary supplements (and some prescription drugs) come from natural sources, but “natural” does not always mean “safe.” For example, the kava plant is a member of the pepper family but taking kava supplements can cause liver disease.
• A manufacturer’s use of the term “standardized” (or “verified” or “certified”) does not necessarily guarantee product quality or consistency.

Safety Considerations

• If you’re going to have surgery, be aware that certain dietary supplements may increase the risk of bleeding or affect your response to anesthesia. Talk to your health care providers as far in advance of the operation as possible and tell them about all dietary supplements that you're taking.
• If you’re pregnant, nursing a baby, trying to get pregnant, or considering giving a child a dietary supplement, consider that many dietary supplements have not been tested in pregnant women, nursing mothers, or children.
• If you’re taking a dietary supplement, follow the instructions on the label. If you have side effects, stop taking the supplement and contact your health care provider. You may also want to contact the supplement manufacturer.

Take charge of your health—talk with your health care providers about any complementary health approaches you use. Together, you can make shared, well-informed decisions.

Excerpts from an educational webinar from NIH's Office of Dietary Supplements, featuring Dr. Paul Thomas and Ms. Carol Haggans.

Dietary supplement use in the United States:

Thomas: Americans spend more on supplements than they do on over-the-counter medications, like products for pain relief, stomach upset, allergies, and the like. One good estimate is almost $49 billion in sales in 2019.

Overall, about half of adults and a third of children take one of more supplements daily, or on most days. For adults, supplement use increases with age. About a third of those [aged] 19 to 30 take them. [This grows] to three-quarters of older people in their 70s and beyond.

People take supplements for many different reasons, but I think we can put them into three major categories. First, some [use] supplements as a form of nutritional insurance, to be sure they get the recommended amounts of nutrients. Another reason is the hope or expectation of better health over the short or long term. Although dietary supplements, by definition, aren’t meant to treat diseases. And then some people take supplements for specific purposes. [For example], a bodybuilder or runner might supplement to see if that improves their strength or performance.

How the Food and Drug Administration (FDA) regulates dietary supplements:

Haggans: If you think about prescription or over-the-counter drugs, we expect them to work as intended and to be safe. FDA doesn’t treat dietary supplements the same. Dietary supplements are regulated as foods and not drugs.

First, they’re [not approved] for effectiveness. So that means that if you take a supplement that’s marketed to help maintain immune system health, or suppress your appetite, it may or may not work.

And likewise, FDA doesn’t approve supplements for safety. And there are no mandatory standards for ingredient combinations or doses. And furthermore, for the FDA to ban a supplement, the burden of proof is on them to prove that it’s unsafe. And sometimes that can be a high bar.

So it’s important to do your homework when considering [if] you should take a supplement. Especially ones that contain ingredients that are less well studied than others, like herbs.

Even though manufacturers don’t have to prove to FDA that their supplements are effective, they’re allowed to make certain claims about them. For example, manufacturers can claim that their product “helps maintain normal cholesterol levels” or “supports the immune system.” But they can’t say that a product “lowers cholesterol” or “has antiviral capabilities.” But you can see that there’s a fine line between what’s allowed and what isn’t. And in reality, many people might interpret those claims [as being the same].

How botanical and herbal supplements are different from vitamins and minerals:

Thomas: There are no guideposts or recommendations for intake [for botanicals], like you have with the daily value for nutrients. So you need to get expert advice on when or if to take [a botanical] product.

For most botanicals, we don’t know what the most important constituents are, or what combinations provide potential health benefits. And one company’s botanical supplement is [going to be] different from another’s. Each contains different amounts and combinations of the [compounds] that might affect your health.

The safety of a botanical depends on many things, like how it’s prepared and the amount you use. For example, peppermint tea is generally considered safe to drink. But peppermint oil taken as a supplement is much more concentrated and can be toxic if used incorrectly.

And be really careful about taking botanical supplements if you also take prescription medications. In some cases, there’s a possibility of an unwanted interaction between the two. For example, St. John’s wort, which some people use for mood disorders, can reduce the effectiveness of many medications, like some birth control pills, anti-depressants, and [organ] transplant drugs.

Questions to ask before taking a supplement:

Thomas: The best advice we can give you is to talk with your health care providers before taking any supplements. Have a discussion with your doctor, pharmacist, registered dietitian, or other provider about which might be useful—or useless—to you. At the very least, let your main providers know what supplements you’re taking and why. Discuss your reasons for taking them and get their reactions.

[Questions to ask can include]: What are the potential benefits for me? Does it have any safety concerns or safety risks? What is the proper dose to take? How, when, and for how long should I take it?

Be especially skeptical of taking a supplement other than a standard vitamin, mineral, or prenatal supplement if you’re pregnant or [breastfeeding]. We often don’t know if an ingredient might affect a developing or nursing baby. Also be skeptical about giving these types of supplements to an infant or child. Many supplements haven’t been well tested for safety in pregnant women, nursing mothers, and kids.

When you take prescription or over-the-counter (OTC) medications, do you also take a vitamin, mineral, or other dietary supplement? Have you considered whether there is any danger in mixing medications and dietary supplements?

There could be. Certain dietary supplements can change absorption, metabolism, or excretion of a medication. If that happens, it can affect the potency of your medication, which means you may get either too much or too little of the medication you need.

Dangers of Mixing Medications and Dietary Supplements

Dietary supplements are widely used and include vitamins, minerals, and other less familiar substances—such as amino acids, botanicals, and botanical-derived ingredients. Tens of millions of people in the U.S. take some kind of dietary supplement along with a prescription medication.

Combining dietary supplements and medications could have dangerous and even life-threatening effects. For example, drugs for HIV/AIDS, heart disease, depression, treatments for organ transplants, and birth control pills are less effective when taken with St. John’s wort, an herbal supplement. Depending on the medication involved, the results can be serious.

In addition, warfarin (a prescription blood thinner), ginkgo biloba (an herbal supplement), aspirin, and vitamin E (a supplement) can each thin the blood. Taking any of these products together may increase the potential for internal bleeding or stroke.

Don’t Assume “Natural” Means Safe

Some consumers may believe that a so-called “natural” product, such as an herbal supplement or fish oil, can’t hurt them. Natural does not always mean safe.

For example, many weight loss products claim to be “all-natural” or “herbal,” but their ingredients may interact with medications or may be dangerous for people with certain medical conditions.

Precautions for Children and for Those Who Are Pregnant or Breastfeeding

Children, in particular, could be harmed by taking both supplements and medicines. Children’s metabolisms are unique, and at different ages they metabolize substances at different rates. For kids, ingesting dietary supplements together with other medications make adverse events a real possibility. And if you’re pregnant or breastfeeding, you’ll want to discuss any dietary supplements with their health care professional.

Considerations Before Surgery

If you’re planning a surgery, be aware that some dietary supplements can interact in a harmful way with medications you need to take before, after, or during that surgery. Your health care professional may ask you to stop taking dietary supplements two or three weeks before the procedure to avoid potentially dangerous changes in heart rate, blood pressure, or bleeding risk.

What Is the FDA’s Role in Dietary Supplements?

Although the FDA has oversight of the dietary supplement industry, the supplement manufacturers and distributors are responsible for making sure their products are safe before they’re marketed. Manufacturers are required to produce dietary supplements that meet minimum quality standards, do not contain contaminants or impurities, and are accurately labeled.

The FDA does not review supplements for effectiveness (as it does for OTC and prescription medications) before they enter the market. If the dietary supplement contains certain new dietary ingredients, the manufacturer must submit data on that ingredient’s safety—but not its effectiveness—for the FDA’s review before the manufacturer markets a dietary supplement containing the ingredient.

The FDA can take enforcement actions against manufacturers if their products are found to be adulterated (for example, if an ingredient is unsafe) and/or misbranded (for example, if their labeling is false or misleading). To the extent a product marketed as a dietary supplement bears claims that the product is intended to diagnose, mitigate, treat, cure, or prevent a disease, the FDA may also consider whether it is appropriate to take action against products that are unlawfully marketed as drugs.

Talk With Your Health Care Professional Before Using Supplements

Before you take any dietary supplement or medication—over-the-counter or prescription—it is important to discuss it with your health care professional.

• Every time you visit a health care professional’s office, bring a list of all the dietary supplements and medications you are currently taking. Include the dosages and how many times a day you take them. Some people find it easiest to throw all their dietary supplements and medications in a bag to bring to the medical visit.
• If you’re thinking of adding a dietary supplement to your daily routine, call your health care professional first, and let them know what other supplements and medications you’re taking.
• Also, tell your health care professional if your health status has changed, particularly if you are pregnant, breastfeeding, or have had any recent illnesses or surgery.

Two types of ingredients may be used in dietary supplements – “dietary ingredients” and “other ingredients.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories.

Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes, and are typically marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids. Dietary supplements may also include other ingredients, such as fillers, binders, excipients, preservatives, sweeteners, and flavorings. These “other ingredients” are listed separately from dietary ingredients on the Supplement Facts label.

To help manufacturers, retailers, and consumers of dietary supplements stay informed about recent developments and locate information on FDA’s website quickly, we have put together an “ingredient directory” with links to FDA’s actions and communications with regard to particular dietary ingredients and other ingredients used in products marketed as dietary supplements. We will update the directory periodically to reflect new developments. The directory is not intended to be a comprehensive list of all ingredients used in products marketed as dietary supplements and may not include all actions the agency has taken with respect to a particular ingredient. 

1. This column includes commonly used names for each ingredient but may not include all synonyms or other known names for an ingredient. In addition, some “other known names” may be ambiguous because some names are used for more than one ingredient.

2. The claim and disclaimers in this letter were incorporated into a settlement agreement as part of the voluntary dismissal of a lawsuit against FDA in June 2001. Pearson v. Thompson, No. 00-2724 (GK) (D.D.C.).

3. The November 2004 letter reevaluated the scientific evidence for the qualified health claim in the May 2003 letter of enforcement discretion but did not change the qualified health claim itself. 

Acacia rigidula is declared as a dietary ingredient on the labeling of some dietary supplements. Under existing law, a “new dietary ingredient” is a dietary ingredient that was not marketed in the United States before October 15, 1994. The FDA is not aware of any information demonstrating that A. rigidula was lawfully marketed as a dietary ingredient in the United States before this date. As a result, A. rigidula is a new dietary ingredient, and dietary supplements that contain A. rigidula must, among other requirements, satisfy one of the following:

1. A. rigidula, and all other new dietary ingredients in the product, must have been present in the food supply as an article used in food in a form in which the food has not been chemically altered; or
2. There must be a history of use or other evidence of safety establishing that A. rigidula, when used under the conditions recommended or suggested in the product labeling, will reasonably be expected to be safe; and at least 75 days before the product is introduced or delivered for introduction into interstate commerce, the manufacturer or distributor must notify the FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing A. rigidula will reasonably be expected to be safe.

Because neither of these conditions has been met by those marketing products that contain A. rigidula as a dietary ingredient, these products are deemed to be adulterated.

Acacia rigidula is also known as:

• Vachellia rigidula
• Chaparro Prieto
• Blackbrush

BMPEA is a substance that does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement.

BMPEA is also known as:

• βMePEA
• R-beta-methylphenethylamine
• R-beta-methylphenethylamine HCl
• Beta-methylphenethylamine
• β-methylphenylethylamine
• 1-amino-2-phenylpropane
• 2-phenylpropan-1-amine
• 2-phenylpropylamine
• alpha-benzylethylamine
• 1-phenyl-1-methyl-2-aminoethane
• beta-methylbenzeneethanamine
• beta-phenylpropylamine
• 2- phenyl-1-propanamine

Cesium chloride is declared as a dietary ingredient on the labeling of some dietary supplements. Under existing law, a “new dietary ingredient” is a dietary ingredient that was not marketed in the United States before October 15, 1994.  The FDA is not aware of any information demonstrating that cesium chloride was lawfully marketed as a dietary ingredient in the United States before this date. As a result, cesium chloride is a new dietary ingredient, and dietary supplements that contain cesium chloride must, among other requirements, satisfy one of the following:

1. Cesium chloride, and all other new dietary ingredients in the product, must have been present in the food supply as an article used in food in a form in which the food has not been chemically altered; or
2. There must be a history of use or other evidence of safety establishing that cesium chloride, when used under the conditions recommended or suggested in the product labeling, will reasonably be expected to be safe; and at least 75 days before the product is introduced or delivered for introduction into interstate commerce, the manufacturer or distributor must notify the FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing cesium chloride will reasonably be expected to be safe.

Because neither of these conditions has been met by those marketing products that contain cesium chloride as a dietary ingredient, these products are deemed to be adulterated.

Cesium chloride is sometimes promoted as an alternative treatment for cancer, but it has never been proven to be safe and effective to treat cancer or for any other use. On February 5, 2020, the FDA warned consumers to avoid using dietary supplements containing cesium salts, including cesium chloride, due to significant safety concerns.

What is DMAA?

DMAA (1,3-dimethylamylamine) is an amphetamine derivative that has been marketed in sports performance and weight loss products, many of which are sold as dietary supplements. DMAA is not a dietary ingredient, and DMAA-containing products marketed as dietary supplements are illegal and their marketing violates the law.

Also known as methylhexanamine or geranium extract, DMAA is often touted as a “natural” stimulant; however, the FDA is not aware of any reliable science indicating that DMAA exists naturally in plants. Although DMAA at one time was approved as a drug for nasal decongestion, it is no longer approved for this use and no medical use of DMAA is recognized today. DMAA, especially in combination with other stimulant ingredients such as caffeine, can be a health risk to consumers. Taking DMAA can raise blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack.

The FDA continues to advise consumers not to buy or use products marketed as dietary supplements that contain DMAA due to the health risks they present.

Is it safe to consume DMAA?

The FDA does not have any information to demonstrate that consuming DMAA is safe. When DMAA is added to a product marketed as a dietary supplement, the FDA considers it to be an unsafe food additive. The FDA is very concerned about DMAA, and we advise consumers not to purchase or use any product containing DMAA. This substance narrows blood vessels and arteries, which can raise blood pressure, and may lead to cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack, as well as seizures and other neurological and psychological conditions.

What is FDA doing to remove DMAA-containing products marketed as dietary supplements from the market?

Over the past several years, the FDA has used different methods to ensure DMAA-containing products are taken off the market. These actions are being taken to protect consumers and get these products off the shelves as quickly as possible.

Starting in 2012, the FDA has issued warning letters to companies notifying them that marketing DMAA-containing products violates the law. When we find products containing DMAA during facility inspections, we discuss our concerns with firms and give them an opportunity to voluntarily recall and destroy these violative products. Most companies warned are no longer distributing products with DMAA.

When firms have chosen not to comply voluntarily, the FDA has taken other actions. In 2013, the FDA administratively detained two DMAA-containing products, OxyElite Pro and Jack3d, after USPLabs initially refused the FDA’s efforts to achieve voluntary compliance. USPLabs ultimately destroyed the detained products – which were estimated to have been worth more than $8 million at the retail level, and agreed to stop manufacturing with DMAA. Also in 2013, the FDA seized DMAA-containing products from Hi-Tech Pharmaceuticals; a federal district court ruled in April 2017 that the products were adulterated and ordered them condemned and forfeited to the United States for destruction. In 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed the lower court ruling, finding that DMAA is not a dietary ingredient and is not generally recognized as safe, and condemning and forfeiting the seized articles containing DMAA. The Supreme Court denied a request from Hi-Tech Pharmaceuticals to review the case in 2020. The products were destroyed on November 12, 2020.

The FDA continues working to get DMAA products off the market when it identifies them. Consumers should not buy or use any product containing DMAA.

How do consumers know if a product marketed as a dietary supplement contains DMAA?

Consumers should look for DMAA listed on the product label. It may also be listed as:

• 1,3-DMAA
• 1,3-Dimethylamylamine
• 1,3-Dimethylpentylamine
• 2-Amino-4-methylhexane
• 2-Hexanamine, 4-methyl- (9CI)
• 4-Methyl-2-hexanamine
• 4-Methyl-2-hexylamine
• Dimethylamylamine
• Geranamine
• Methylhexanamine
• Methylhexanenamine

Some products will also list Pelargonium graveolens extract or Geranium extract, which may indicate that the product contains DMAA.

What should consumers do if they believe they’ve been harmed by consuming DMAA- containing products marketed as dietary supplements?

Consumers who believe they have been harmed by using a DMAA-containing product should contact their health care practitioner. Consumers can also report such incidents directly to the FDA through the Safety Reporting Portal. In addition, consumers can also report these adverse events to the company whose name and contact information is on the product label. 

DMBA is declared as a dietary ingredient on the labeling of some dietary supplements. Under existing law, a “new dietary ingredient” is a dietary ingredient that was not marketed in the United States before October 15, 1994. The FDA is not aware of any information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before this date. As a result, DMBA is a new dietary ingredient, and dietary supplements that contain DMBA must, among other requirements, satisfy one of the following:

1. DMBA, and all other new dietary ingredients in the product, must have been present in the food supply as an article used in food in a form in which the food has not been chemically altered; or
2. There must be a history of use or other evidence of safety establishing that DMBA, when used under the conditions recommended or suggested in the product labeling, will reasonably be expected to be safe; and at least 75 days before the product is introduced or delivered for introduction into interstate commerce, the manufacturer or distributor must notify the FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing DMBA will reasonably be expected to be safe.

Because neither of these conditions has been met by those marketing products that contain DMBA as a dietary ingredient, these products are deemed to be adulterated.

DMBA is also known as:

• 1,3-Dimethylbutylamine
• 2-Amino-4-Methylpentane Citrate
• 4-Amino-2-Methylpentane Citrate
• 4-Amino Methylpentane Citrate
• Amperall
• AMP
• AMP Citrate
• 4-AMP Citrate
• 4-Methyl-2-Pentanamine

FDA considers DMHA to be a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive. Accordingly, we consider dietary supplements containing DMHA to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Our reasoning follows. 

Under the FD&C Act, dietary supplements must contain at least one “dietary ingredient.” A “dietary ingredient” is a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories. Non-dietary ingredients intended for use in dietary supplements must be used in accordance with a food additive regulation or be generally recognized as safe (GRAS) for their intended use, unless they meet one of the other listed exceptions to the food additive definition. Because DMHA does not qualify as a dietary ingredient, is not an approved food additive, is not GRAS, and does not meet any of the other listed exceptions to the food additive definition, it is an unsafe food additive, and dietary supplements containing DMHA are adulterated under the FD&C Act.

DMHA is also known as:

• 1,5-Dimethylhexylamine
• 1,5-DMHA
• 2-amino-5-methylheptane
• 2-amino-6-methylheptane
• 2-aminoisoheptane
• 2-Heptylamine, 6-methyl-
• 2-Isooctyl amine
• 2-Metil-6-amino-eptano
• 6-Amino-2-methylheptane
• Amidrine
• Octodrine
• Vaporpac

Methylsynephrine is a substance that does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Methylsynephrine does not fit under any of these categories, rendering misbranded any dietary supplement products that declare methylsynephrine as a dietary ingredient.

Methylsynephrine is also known as:

• oxilofrine
• p-hydroxyephedrine

Phenibut is a substance that does not meet the statutory definition of a dietary ingredient.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Because phenibut does not fit any of the categories of dietary ingredients under the FD&C Act, any dietary supplements that declare phenibut as a dietary ingredient are misbranded.

Phenibut is also known as:

• fenibut
• phenigam
• PhGaba
• Phenigamma
• Phenygam
• 4-Amino-3-phenylbutanoic acid
• β-(aminomethyl)benzenepropanoic acid
• beta-(Aminomethyl)hydrocinnamic acid
• β-phenyl-γ-aminobutyric acid

Picamilon is a substance that does not meet the statutory definition of a dietary ingredient.

The Federal Food, Drug, and Cosmetic Act (the Act) defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. In contrast, picamilon is a unique chemical entity synthesized from the dietary ingredients niacin and gamma-aminobutyric acid. Picamilon is absorbed into the body, crosses the blood-brain barrier and accumulates in the brain as a separate chemical entity. Because picamilon does not fit any of the categories of dietary ingredients under the Act, any products marketed as dietary supplements that declare picamilon as a dietary ingredient are misbranded.

The FDA has provided expert testimony to the Oregon Attorney General’s office stating that picamilon is not a dietary ingredient.

Picamilon is used as a prescription drug in Russia for a variety of neurological conditions. It is not approved as a drug in the U.S.

Picamilon is also known as:

• pikatropin
• pikamilon
• nicotinyl-gamma-aminobutyric acid
• nicotinyl-GAB

Pure and highly concentrated caffeine products present a significant public health threat and have contributed to at least two deaths in the United States.

In recent years, dietary supplement products consisting of pure or highly concentrated caffeine in powder and liquid forms have emerged on the market. These products are often marketed in bulk packaging with up to thousands of servings per container, requiring the consumer to measure out a safe serving from what can be a toxic or even lethal amount of bulk product.

The difference between a safe amount and a toxic or life-threatening amount of caffeine in these highly concentrated products is very small. Safe quantities of these products can be difficult or nearly impossible to measure accurately with common kitchen measuring tools. For many of these products, volume measures such as teaspoons are not precise enough to calculate how many milligrams of caffeine are in the recommended serving size. These products are also often sold in ways that increase the likelihood of accidental measurement error.

Just one teaspoon of pure powdered caffeine can contain the same amount of caffeine as 28 cups of coffee, and a half cup of a liquid highly concentrated caffeine product contains the equivalent of more than 20 cups of coffee. These are toxic amounts that can have serious health consequences.

While consumers of commonly available caffeinated products such as coffee, tea, and soda may be aware of caffeine’s less serious effects – such as nervousness and tremors – they may not be aware that these pure and highly concentrated caffeine products are much more potent and can cause serious health effects, including rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. Pre-existing conditions can intensify the effects of caffeine and make these products even more dangerous for some individuals.

Tianeptine is a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive.

Under the Federal Food, Drug, and Cosmetic Act (the Act), dietary supplements must contain at least one “dietary ingredient” but can also contain non-dietary ingredients, subject to applicable requirements. A “dietary ingredient” is a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Non-dietary ingredients intended for use in dietary supplements must be used in accordance with a food additive regulation or be generally recognized as safe (GRAS). Because tianeptine does not qualify as a dietary ingredient, is not an approved food additive, and is not GRAS, dietary supplements containing tianeptine are adulterated under the Act.

Tianeptine is used as a prescription drug in some European, Asian, and Latin American countries, but it is not approved as a drug in the U.S. The FDA is aware of several serious adverse event reports associated with tianeptine.

Tianeptine is also known as:

• Tianeptine sulfate
• Tianeptine sodium powder
• Tianaa
• Tianna Green
• Tianna Red
• Tianna White

Consumers may inadvertently find themselves addicted to tianeptine and should avoid all products containing tianeptine, especially those claiming to treat opioid use disorder (OUD). Reliance on products with unsubstantiated claims may delay those who suffer from OUD from entering recovery and may put them at greater risk of overdose and death. Consumers with OUD should consult their healthcare provider for treatment options.

Vinpocetine is a synthetic compound that is derived from vincamine, an alkaloid found in the Vinca minor L. plant. Vinpocetine can also be derived from tabersonine, an alkaloid found in Voacanga seeds. According to the information we’ve reviewed, vinpocetine is not a constituent of these plants, or of any other plants. Instead, it is synthetically produced.

On September 6, 2016 the FDA announced its tentative conclusion that vinpocetine (1) does not meet the definition of a dietary ingredient, and (2) is excluded from the definition of a dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The agency is accepting comments on this tentative conclusion until November 7, 2016.

According to a report by NIH’s National Toxicology Program, dietary supplements containing vinpocetine are marketed for uses that include improvement of brain function, rapid weight loss and/or fat loss, increases in energy, and improvement in visual acuity, memory, and focus. Vinpocetine is also reportedly marketed for uses including the prevention of motion sickness and the treatment of menopausal symptoms, chronic fatigue syndrome, seizure disorders, and hearing and eye disorders. The FDA has not assessed whether vinpocetine is effective for any of these uses.

Vinpocetine is also known as:

• Ethyl Apovincaminate
• Common Periwinkle Vinpocetine
• Lesser Periwinkle extract
• Vinca minor extract

You may know someone who has been unable to get pregnant due to infertility issues. According to the Centers for Disease Control and Prevention, about 12 percent of women aged 15 to 44 in the United States have difficulty becoming pregnant or carrying a pregnancy to term.

"Fertility” Products Prey on Vulnerability

Marketers are targeting this population by pitching dietary supplements that make unproven claims to cure, treat, mitigate, or prevent infertility and other reproductive health conditions. Some women may have had difficulties conceiving or have underlying health conditions that put them at risk of infertility.

Under the Federal Food, Drug, and Cosmetic Act, claims to prevent, treat, or cure such conditions establish that a product is a new drug and must be approved by the Food and Drug Administration (FDA) before it can be safely marketed. In fact, dietary supplements making claims about infertility are not FDA approved and could deter patients from seeking effective, FDA-approved drug products.

These purported fertility aids seek to profit off of the vulnerability and frustration many may feel as they face difficulties in getting pregnant. Relying on ineffective, unproven products can be a waste of time and money and can possibly result in illness or serious injury.

Most of these unapproved drugs are sold online and many are falsely labeled as dietary supplements. It is important to know that these products are not based on proven scientific information, and they have not been reviewed for safety and efficacy.

Be Wary of Unproven Claims Regarding Infertility

Your first course of action is always to talk to your health care provider before buying or using any over-the-counter product, including those labeled as dietary supplements.

One of the best ways to protect yourself from fake treatments is to ask whether a claim sounds too good to be true or if it contradicts what you’ve heard from reputable sources about treating infertility. Companies selling unproven infertility or pregnancy-related therapies often include a range of unsupported and expansive claims about the supposed effectiveness of their products. Some of these claims may be framed as consumer testimonials. These include statements such as:

• “You will get pregnant very fast and give birth to healthy children regardless of … how severe or chronic your infertility disorder.”
• " … a perfect natural alternative to infertility drugs or invasive treatments.”
• “best fertility supplements to boost your chance of pregnancy or improve your IVF success rate.”
• “… treat infertility… effectiveness in preventing recurrent miscarriages during early stage pregnancy."

Also be wary of statements containing language such as the following:

• “One product does it all.”
• “Miracle cure” or “scientific breakthrough.”
• Products claiming to be a “cure all.”

If you buy imported products marketed as “dietary supplements” and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, watch out. Health fraud scams abound. Health scammers often target advertising to people who prefer to shop at nontraditional places, especially those who have limited English proficiency and limited access to health care services and information.

Companies that sell fraudulent health products know that ethnic groups who may not speak or read English well, or who hold certain cultural beliefs, can be easy targets for health scams. For example, Native Americans, Latinos, Asians and Africans may have a long tradition of turning to more herbal or so-called “natural” remedies. Many advertisers put the word “natural” somewhere on the package of a product, knowing it inspires trust in certain groups.

“Natural” Does Not Mean “Safe”

But just because a product claims to be natural doesn’t necessarily mean it’s safe. Likewise, just because a product claims to be natural does not mean that it’s free of hidden drug ingredients.

Furthermore, these products may also be contaminated or contain potentially harmful chemicals or drug ingredients not listed on the label.

For example, many products that claim to help people lose weight contain hidden and dangerous prescription drug ingredients such as sibutramine. Sibutramine was in Meridia, a formerly FDA-approved drug that was removed from the market in October 2010 because clinical data indicated it posed an increased risk of heart problems and strokes.

And just because an ingredient is contained in an FDA-approved drug product does not mean it is safe in the dosages or amounts used in these nonprescription products. Moreover, scammers seek out ethnic populations who are overweight or have serious conditions such as cancer, HIV/AIDS, diabetes, or heart disease. They target consumers looking for easy—and sometimes less expensive—solutions to difficult problems. Using these products could mean delayed treatment for serious diseases.

Others illegally sell imported antibiotics without a prescription and with no physician oversight. This can easily lead to misuse and overuse, a key factor contributing to antibiotic resistance, meaning they might not be as effective in stopping infections when they’re truly needed. And some products marketed as dietary supplements resemble antibiotic products marketed in foreign countries—but actually don’t contain any antibiotics.

You may see these products advertised in ethnic newspapers, magazines, online, infomercials on radio and TV stations or in ethnic stores, flea markets, and swap meets, which may stock products claiming to be from, for example, Latin America or Asia. But that does not guarantee the product is safe or effective.

By the same token, products with the claim “Made in the USA” may not be made here. Consumers sometimes see this claim as an assurance of safety, but any scammer can slap the label on, and buyers are none the wiser.

In fact, the law does not require companies who make dietary supplements to get FDA approval before marketing their products.

Dietary supplements are not drugs. Nor are they substitutes for the drugs your health care professional prescribes. Be sure to tell your health care professional what supplements you are taking, because supplements may interact in a harmful way with prescribed medications or keep a prescribed drug from working.

How Do You Know It’s Fraudulent?

Watch out for these claims:

• One product does it all. Be suspicious of products that claim to cure a wide range of diseases.
• Personal testimonials. Success stories such as “It cured my diabetes,” or “My tumors are gone,” are easy to make up and are not a substitution for scientific evidence.
• Quick fixes. Few diseases or conditions can be treated quickly, even with legitimate products. If claims sound too good to be true, they probably are. Beware of language such as “lose 30 pounds in 30 days,” or “eliminates skin cancer in days.”
• “All natural.” Some plants found in nature can kill if you eat them. Plus, the FDA has found products promoted as “all natural” that contain hidden and dangerously high doses of prescription drug ingredients.
• Miracle cure. Alarms should go off when you see this claim or others like it such as “new discovery” or “scientific breakthrough.” A real cure for a serious disease would be all over the media and prescribed by doctors—not buried in print ads, TV infomercials, or on Internet sites.
• FDA-approved. Domestic or imported dietary supplements are not approved by the FDA.

Finally, if you're tempted to buy an unproven product or one with questionable claims, check with your doctor or other health care professional first. You can also check the FDA’s website to see if the agency has already taken action on it.

Have a Bad Reaction? The FDA Wants to Hear From You

Suppose you or someone in your family uses a product and has a bad reaction to it. That’s something the FDA wants to know about so it can investigate and, if the product is found to be harmful, make sure appropriate action is taken.

You can report a bad reaction or a product defect by calling the Consumer Complaint Coordinator in your state. Or you can report online to the FDA’s MedWatch. Your report will remain confidential.

Bogus product! Danger! Health fraud alert!

You’ll never see these warnings on health products, but that’s what you ought to be thinking when you see claims like “miracle cure,” “guaranteed results,” or “vaccine alternative.”

Health fraud scams have been around for hundreds of years and play on the desire for a quick or miracle cure. The snake-oil salesmen of old have morphed into the deceptive, high-tech marketers of today, preying on people’s desires for easy solutions to difficult health problems—including Alzheimer’s, arthritis, cancer, diabetes, memory loss, sexual performance, weight loss, and Coronavirus Disease 2019 (COVID-19), influenza and other infectious diseases.

According to the Food and Drug Administration (FDA), a health product is fraudulent if it is deceptively promoted as being effective against a disease or health condition, but not scientifically proven safe and effective for that purpose.

Not Worth the Risk

Scammers promote their products with savvy marketing, often using tactics that target specific populations via the web and email, but also by word-of-mouth, newspapers, magazines, TV, and direct mail. Health fraud scams run rampant on social media sites and closed messaging apps, such as Signal, Viber, WhatsApp and Facebook Messenger.

Health fraud scams can also be found in other locations such as convenience stores, gas stations, flea markets and nontraditional stores, targeting those with limited English proficiency and limited access to health care services and information. Other risks include potentially dangerous or unproven products ordered direct from overseas sources via mail to circumvent normal Customs and FDA inspections and other safety measures.

Consumers can increase their chances of identifying and avoiding health fraud scams by focusing on being smart, aware and careful when purchasing health care products.

Tip-Offs

Here are six tip-offs to help you identify rip-offs.

1. One product does it all. Be suspicious of products that claim to cure a wide range of diseases. The agency continues to send warning letters and take enforcement action as appropriate against companies marketing fake cure-all products. These miracle cures don’t exist - they’re bogus – and the only thing these companies are selling is false hope.
2. Personal "success" testimonials. Success stories, such as, “It cured my diabetes” or “It immediately stopped my COVID-19 infection,” are easy to make up and are not a substitute for scientific evidence. Reviews found on popular online marketplaces and social media can be fake.
3. Quick fixes. Few diseases or conditions can be treated quickly, even with legitimate products. Beware of language such as, “Lose 30 pounds in 30 days,” “protects from viral infections,” or “eliminates skin cancer in days.”
4. “All natural” cure or treatment. Don't be fooled by descriptions like "all-natural cure." Such phrases are often used in health fraud as an attention-grabber to suggest that a product is safer than conventional treatments. These terms don't necessarily equate to safety. Some plants found in nature (such as poisonous mushrooms) can be harmful or even kill when consumed. Moreover, the FDA has found numerous products promoted as “all-natural” cures or treatments that contain hidden and dangerously high doses of prescription drug ingredients or other active pharmaceutical ingredients.
5. “Miracle cure.” Alarms should go off when you see this claim or others like it such as, “new discovery,” “guaranteed results,” or “secret ingredient.” If a real cure for a serious disease were FDA-approved, it would be widely reported through the media and prescribed by licensed health professionals—not plastered on advertisements in social media and messaging apps, or buried in websites, print ads, and TV infomercials.
6. Conspiracy theories. Claims like “This is the cure our government or Big Pharma doesn’t want you to know about” are used to distract consumers from the obvious, common-sense questions about the so-called miracle cure.

A Pervasive Problem

Fraudulent products not only can’t deliver on their baseless promises—they could cause serious injury, or even death. Besides wasting money and delaying potentially life-saving diagnosis and scientifically tested and proven treatments, fraudulent products sometimes contain hidden drug ingredients that can be harmful when unknowingly taken by consumers.

For example, in recent years, FDA laboratories have found hundreds of weight-loss products, illegally marketed as dietary supplements, that contained sibutramine, a Schedule IV controlled substance and the active ingredient in a prescription weight-loss drug. This prescription drug was later withdrawn from the U.S. market after studies showed that it was associated with an increased risk of heart attack and stroke. Furthermore, fraudulent products may be manufactured by unregistered facilities under unknown, unclean, or dangerous conditions.

Health fraud scams can involve a variety of FDA-regulated products. For example, the FDA found an expensive laser device being sold with fraudulent cure-all claims to treat cancer, HIV/AIDS and diabetes. Three individuals were sentenced to prison for their involvement in the $16.6 million fraudulent scheme to distribute misbranded devices.

Even with these tips, fraudulent health products are not always easy to spot. If consumers are tempted to buy an unproven product or one with questionable claims, they should check with their doctor or other health care professional first.

Q. How do I know if I need a dietary supplement?

A. Many products are marketed as dietary supplements, and it is important to remember that supplements include not only vitamins and minerals, but also herbs and other botanicals, probiotics, fish oil, and other substances.

Some supplements may help ensure that you get adequate amounts of essential nutrients or help promote optimal health and performance if you do not consume a variety of foods.

However, dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.

Do not self-diagnose any health condition. Work with your healthcare provider to determine how best to achieve optimal health. Also check with your healthcare provider before taking a supplement, especially if you take any medicines or other dietary supplements or if you have any health conditions.

Q. How can I get more information about a particular dietary supplement such as whether it is safe and effective?

A. Scientific evidence supporting the benefits of some dietary supplements (for example, vitamins and minerals) is well established for certain health conditions, but others need further study.

Research studies in people to prove that a dietary supplement is safe are not required before the supplement is marketed, unlike for drugs. This is due to the way dietary supplements are regulated by the U.S. Food and Drug Administration (FDA). It is the responsibility of dietary supplement manufacturers/distributors to ensure that their products are safe and that their label claims are truthful and not misleading. If the FDA finds a supplement to be unsafe once it is on the market, only then can it take action against the manufacturer and/or distributor, such as by issuing a warning or requiring the product to be removed from the marketplace.

The manufacturer does not have to prove that the supplement is effective, unlike for drugs. The manufacturer can say that the product addresses a nutrient deficiency, supports health, or reduces the risk of developing a health problem, if that is true. If the manufacturer does make a claim, it must be followed by the statement “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions. Supplements should not replace prescribed medications or the variety of foods important to a healthful diet.

Do not self-diagnose any health condition. Work with your healthcare provider to determine how best to achieve optimal health. Also, check with your healthcare provider before taking a supplement, especially if you take any medicines or other dietary supplements or if you have any health conditions.

Q. Where can I find information about the use of dietary supplements for a particular health condition or disease?

A. Scientific evidence supporting the benefits of some dietary supplements (e.g., vitamins and minerals) is well established for certain health conditions, but others need further study. Whatever your choice, supplements should not replace prescribed medications or the variety of foods important to a healthy diet.

Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.

Do not self-diagnose any health condition. Work with your healthcare provider to determine how best to achieve optimal health. Also, check with your healthcare provider before taking a supplement, especially if you take any medicines or other dietary supplements or if you have any health conditions.

Q. What does the Supplement Facts label on a dietary supplement tell me?

A. All products labeled as dietary supplements carry a Supplement Facts label that is similar to the Nutrition Facts label found on food products. It lists the active ingredients and their amounts, plus other added ingredients like fillers, binders, and flavorings. It also gives a suggested serving size, but you and your healthcare provider might decide that a different amount is more appropriate for you.

In the Supplement Facts label, the amounts of vitamins, minerals, and other nutrients like dietary fiber are listed as a percentage of the Daily Value or %DV. Each nutrient has one DV that applies to all people age 4 and older. For example, the DV for vitamin C is 90 milligrams (mg) and the DV for the B-vitamin biotin is 30 micrograms (mcg).

The %DV allows you to see how much a product contributes to your approximate daily needs for that nutrient. For example, if a supplement provides 50% of the DV for calcium, it contributes about half of your daily needs for calcium.

Q. What is the difference between the RDA and DV for a vitamin or mineral?

A. Many terms are used when referring to either the amount of a particular nutrient (such as calcium or vitamin D) you should get or the amount in a food or dietary supplement. The two most common are the Recommended Dietary Allowance (RDA) and the Daily Value (DV). These terms can be confusing.

RDAs are recommended daily intakes of a nutrient for healthy people. They tell you how much of that nutrient you should get on average each day. RDAs are developed by the Food and Nutrition Board of the National Academies of Sciences, Engineering, and Medicine. They vary by age, sex, and whether a woman is pregnant or breastfeeding; so there are many different RDAs for each nutrient.

DVs, established by the U.S. Food and Drug Administration (FDA), are used on food and dietary supplement labels. For each nutrient, there is one DV for all people ages 4 years and older. Therefore, DVs aren’t recommended intakes, but suggest how much of a nutrient a serving of the food or supplement provides in the context of a total daily diet. DVs often match or exceed the RDAs for most people, but not in all cases.

DVs are presented on food and supplement labels as a percentage. They help you compare one product with another. As an example, the %DV for calcium on a food label might say 20%. This means it has 260 mg (milligrams) of calcium in one serving because the DV for calcium is 1,300 mg/day. If another food has 40% of the DV for calcium, it’s easy to see that it provides much more calcium.

Q. What are the Upper Limits (ULs) for vitamins and minerals?

A. Our bodies need vitamins and minerals for many things, like breaking down the food we eat, making bones and DNA, helping muscles contract, and maintaining immunity. But there’s no reason to get more than you need, and some nutrients can be dangerous in large amounts.

Each vitamin and mineral has a recommended amount, which is what you should get each day for good health. Most of them also have what is called a “tolerable upper intake level” or UL. Getting more than the UL can cause health problems. Other vitamins and minerals appear to be safe at any dose, while a few have a UL only under certain circumstances.

Which vitamins and minerals fall into which category? Here’s the breakdown:

• Nutrients with ULs: calcium, choline, copper, fluoride, iodine, iron, manganese, molybdenum, nickel, phosphorus, selenium, vitamin B6, vitamin C, vitamin D, and zinc

  Stay under the UL each day for these nutrients to avoid health problems unless your healthcare provider recommends more. For example, very high doses of vitamin B6 can cause severe nerve damage and too much iron can be fatal. The ULs for these nutrients include what you get from food, beverages, fortified foods (including many breakfast cereals), and dietary supplements. But it’s unlikely you’ll go above the UL from food and beverages alone.

• Nutrients with ULs, but only from dietary supplements and fortified foods: folate, magnesium, niacin, and vitamin E

  These vitamins and minerals, as found naturally in food and beverages, won’t cause any health problems. But they can if you get amounts above the UL from supplements or fortified foods.

• One nutrient with a UL, but only for certain forms: vitamin A

  Vitamin A exists in two main forms: preformed vitamin A—such as retinol and retinyl palmitate—in animal products (including meat, poultry, fish, and dairy products); and beta-carotene (in fruits, vegetables, and other plant foods). Dietary supplements can contain both forms.

  Only preformed vitamin A has a UL because high amounts can cause health problems, such as birth defects during pregnancy and liver damage. Beta-carotene has no UL because high amounts don’t cause these problems.

• Nutrients with no ULs: biotin, chromium, pantothenic acid, riboflavin, thiamin, vitamin B12, and vitamin K

  These nutrients have no identified safety concerns, even at high doses. But there’s no reason to get more than recommended amounts unless your healthcare provider recommends it.

Q. Where can I find information about the use of dietary supplements for a particular health condition or disease?

A. Scientific evidence supporting the benefits of some dietary supplements (for example, vitamins and minerals) is well established for certain health conditions, but others need further study. Whatever your choice, supplements should not replace prescribed medications or the variety of foods important to a healthy diet.

Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.

Do not self-diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health. Also, check with your health care provider before taking a supplement, especially if you take any medicines or other dietary supplements or if you have any health conditions.

Q. Should I take a dietary supplement during the COVID-19 pandemic?

A. Like many people, you might wonder if you should take a dietary supplement to increase your immunity or improve your overall health in these unprecedented times. Some of you have asked us, for example, whether to take zinc or vitamin C, or if copper kills the COVID-19 virus.

There is no scientific evidence that any vitamin, mineral, or other dietary supplement can prevent or cure COVID-19. In fact, the U.S. Food and Drug Administration has issued warning letters to many companies for selling products that claim to prevent, treat, or cure this infection.

Your health care provider and the Centers for Disease Control and Prevention (CDC) are the best sources of information on how to protect yourself and others from COVID-19. For zinc, vitamin C, and other nutrients, here’s what you need to know:

• Everyone needs vitamins and minerals for good health. The amounts you need, which are based mainly on your age and sex, include what you get from the foods and beverages you consume, as well as any supplements you take. So, whether you need a vitamin or mineral supplement largely depends on how much you already get from the foods and beverages you consume.
• Vitamins and minerals have unique roles in the body. Calcium, for example, helps keep your bones strong. Iron is needed to make hemoglobin, which carries oxygen from your lungs to the rest of your body.
• Our bodies need some nutrients for a healthy immune system. Certain nutrients, including zinc, vitamin C, vitamin D, and vitamin E help keep your immune system strong. Therefore, if you have a deficiency, your immunity will be lower, and you might be more likely to get sick. But unless you have a deficiency, taking more vitamins and minerals won’t increase your immunity. It’s like baking bread that needs one packet of yeast. Adding more yeast won’t do any good.
• High doses of some vitamins and minerals can cause health problems. Many vitamins and minerals have “upper limits” because they are unsafe at high doses. Getting too much zinc, for example, can cause nausea and vomiting, and high amounts of copper can cause liver damage. In addition, many nutrients, like vitamin E, can interact or interfere with certain medications.
• Focus on eating a nutritious variety of foods for good health and a strong immune system. Following a healthy eating pattern that includes fruits, vegetables, whole grains, and protein can help you get the nutrients your body needs.
• Take a supplement if your health care provider recommends it. Talk with your health care provider for advice because dietary supplements may be recommended in some circumstances. For example, people who smoke need more vitamin C than nonsmokers; older adults and people with dark skin might not get enough vitamin D; and some vegetarians might not get enough zinc or vitamin B12.

Q. My son has attention deficit hyperactivity disorder (ADHD) and I want to avoid using medications. Are there any dietary supplements that might help?

A. Many parents wonder if dietary supplements can help their children with ADHD. Unfortunately, most supplements have not been proven to help people with ADHD and some could be dangerous—so it’s important to be careful. If you’re considering natural therapies such as dietary supplements for your son, look for information from reliable sources and talk with his health care provider.

Vitamins and minerals are some of the most common supplements promoted for ADHD. If your son has a vitamin or mineral deficiency, his health care provider might recommend changes to his diet or specific dietary supplements. But beyond that, taking extra vitamins and minerals won’t necessarily help. And keep in mind that high doses of some vitamins and minerals can be harmful.

Scientists are studying other dietary supplements, such as fish oil, to see if they hold promise for ADHD. But this research is still in its early stages, so we don’t know if these products are effective.

Q. I get colds a lot, and I’ve thought about trying echinacea. Since it’s a natural herb, it should be safe, right?

A. Not necessarily. Even though herbal products, such as echinacea, are “natural,” that doesn’t mean that they are always safe or good for you. The safety of an herbal supplement depends on many things, such as its chemical makeup, how it works in the body, how it’s prepared, and how much you take. Many supplements contain active ingredients that can have strong effects in the body and can interact with certain prescription drugs in ways that might cause problems.

Always be alert to the possibility of unexpected side effects, especially when taking a new product. Echinacea does not usually cause serious side effects, although it sometimes causes nausea, stomach pain, diarrhea, or vomiting, and allergic reactions can occur.

Unfortunately, study results on echinacea are mixed, so it is not clear at this time whether echinacea prevents or treats upper respiratory tract infections, such as the common cold.

Q. Can vitamin C prevent colds or make them shorter?

A. This is a common question and one that many scientists have tried to answer. Overall, the research shows that for most people, taking vitamin C regularly does not reduce the chances of getting the common cold. Vitamin C supplements might slightly shorten the duration of a cold and lessen its severity. However, taking vitamin C after the onset of cold symptoms doesn’t appear to help.

Taking too much vitamin C can cause diarrhea, nausea, and stomach cramps. Most adults need between 75 and 90 milligrams (mg) of vitamin C per day and shouldn’t get more than 2,000 mg.

Q. Some dietary supplements contain high doses of biotin and are promoted for hair, skin, and nail health. Do they work?

A. Biotin is a B vitamin found mainly in meat, eggs, fish, nuts, and some vegetables. A biotin deficiency can cause skin rashes, hair loss, and brittle nails—hence, the belief that taking extra biotin will produce healthier skin, thick hair, and strong nails. But it’s not clear if these claims hold up.

One of the most common misconceptions about vitamins and minerals is that if a nutrient deficiency causes a particular set of symptoms, then taking more of that nutrient will not only reverse those symptoms but will actually leave you better off. The reality is, if you are already getting enough, getting more doesn’t usually help.

Biotin helps metabolize the food we eat into the energy we need. The recommended amount of biotin for adults is 30 micrograms (mcg) per day, and you can get this much by eating a wide variety of nutritious foods. For example, a meal with 3 ounces of salmon, 3/4 cup of cooked sweet potato, 1/2 cup of cooked spinach, 1/4 cup of roasted almonds, and 1 cup of 2 percent milk provides about 11 mcg of biotin.

Some dietary supplements contain between 2,500 and 5,000 mcg of biotin, which are very high doses. In a few small scientific studies, some people with thin and brittle nails who took high doses of biotin had harder nails. And in a few cases, high doses of biotin improved a rare hair disorder in children and skin rash in infants. But the results of these studies are too preliminary to recommend biotin for any of these conditions.

Biotin doesn’t have an upper intake limit because there’s no evidence that it’s toxic, even at high doses. Most vitamins and minerals, however, do have upper limits, and getting too much can be unsafe. Some can also interact with medications or lab tests. Biotin, for example, can cause false results on some lab tests, including those that measure thyroid hormone levels. For these and other reasons, we always recommend talking with your health care provider about vitamins, minerals, and other dietary supplements to help you determine which, if any, may be of value.

Q. I know that the B vitamin folic acid helps prevent birth defects, so it’s important to take during pregnancy, but why are women supposed to take it before getting pregnant?

A. Yes, getting enough folic acid helps prevent birth defects, especially a kind called neural tube defects. These types of birth defects occur when the neural tube (where the brain and spinal cord form) doesn’t close properly in the fetus.

The neural tube closes very early in pregnancy—only 3 to 4 weeks after conception. This is right around the time most women realize they are pregnant, so waiting to take folic acid until you find out that you are pregnant might be too late.

If you could become pregnant, you should get 400 micrograms (mcg) of folic acid per day from dietary supplements and/or fortified foods (such as enriched breads, cereals, pastas, and other grain products). This is in addition to the amount you get naturally from foods and beverages. The recommended amount goes up to 600 mcg per day once a woman is pregnant because folic acid has many other important functions during the remaining months of pregnancy.

Q. Can vitamin B6 reduce the symptoms of premenstrual syndrome (PMS)?

A. Vitamin B6 may be helpful for PMS, but scientists aren’t sure. Some research shows that taking vitamin B6 supplements (about 80 milligrams [mg] per day) might reduce PMS symptoms including moodiness, irritability, forgetfulness, bloating, and anxiety. But more research is needed to confirm these findings. In addition, it’s important to know that taking too much vitamin B6 as a supplement—more than 100 mg per day for adults—can cause severe nerve damage and other health problems.

If you want to try vitamin B6 for PMS, talk with your health care provider first.

Q. Is magnesium helpful for muscle cramps?

A. As with all vitamins and minerals, it’s important to get enough magnesium for good health. Muscle cramps are one of the signs of a magnesium deficiency, so if you are not getting enough magnesium, getting more might help. But in most cases, muscle cramps are caused by other things. We recommend talking with your health care provider to determine if muscle cramps, or any other symptoms you have, might be a sign of a magnesium deficiency or something else.

Q. Can magnesium help prevent migraine headaches?

A. Research shows that people who get migraine headaches tend to have lower levels of magnesium than those who don’t. This suggests—but doesn’t prove—that consuming more magnesium might decrease the chance of getting migraines.

According to a few small studies, taking magnesium supplements (about 300 milligrams [mg] twice a day) alone or in combination with medication might help prevent migraines. But this should be done only under the guidance of a health care provider because taking too much magnesium as a supplement can cause problems. If you want to try magnesium for migraine headaches, we recommend talking with your health care provider.

Q. Can potassium help lower my blood pressure?

A. Yes, it might. People with low intakes of potassium have an increased risk of high blood pressure, especially if you consume a lot of sodium (salt). Therefore, increasing your potassium intake, along with decreasing sodium intake, might help lower your blood pressure and reduce your risk of stroke. One way to do this is to follow an eating plan called DASH (Dietary Approaches to Stop Hypertension), which emphasizes potassium from fruits, vegetables, and low-fat dairy products. Also, using potassium-containing salt substitutes in place of regular salt helps lower blood pressure. But it’s not clear whether this is because of the increased potassium, reduced sodium, or both.

Q. Are fish oil supplements recommended for cardiovascular disease? What does the latest research show?

A. Fish oil supplements help lower triglyceride levels, but their other effects on cardiovascular disease are less clear. Studies conducted 15 to 25 years ago found that fish oil reduced the risk of some heart problems such as sudden death and stroke, especially among people with heart disease. But many recent studies have not found the same thing. Some researchers believe that changes in people’s lifestyles, such as increased use of statins and higher consumption of fish over the last 15 to 25 years, might overshadow the potential benefits of fish oil. Research clearly shows that eating fish and other seafood as part of a healthy eating pattern reduces the risk of cardiovascular disease. Therefore, experts recommend consuming 8 or more ounces per week of fish and other seafood, including some varieties that have higher amounts of EPA and DHA (such as salmon, mackerel, and tuna).

Q. I have macular degeneration, and my ophthalmologist suggested taking a dietary supplement to preserve my vision as long as possible. Is there research to back this up, and if so, which supplement should I buy?

A. Many dietary supplements promoted for vision or eye health are based on formulations tested in the Age-Related Eye Disease Studies (AREDS), a series of large clinical trials sponsored by the National Institutes of Health. These studies found that among people with age-related macular degeneration (AMD) who were at high risk of developing advanced AMD, supplements containing vitamin E, vitamin C, zinc, copper, and either beta-carotene or lutein plus zeaxanthin helped slow down the rate of vision loss. Adding the omega-3 fatty acids EPA and DHA to the supplements didn’t help, but it didn’t do any harm either.

The types and amounts of ingredients in commercially available eye-health supplements vary. We recommend asking your health care provider to make a recommendation.

Q. I suffer from migraine headaches, and I’ve heard that riboflavin might help. Is riboflavin safe to take for migraines?

A. Riboflavin is a B vitamin that is sometimes called vitamin B2. A number of foods, including eggs, organ meats (such as kidneys and liver), lean meats, low-fat milk, and green vegetables, contain riboflavin. It’s also added to enriched cereals, bread, and grain products.

Some studies show that riboflavin supplements might help prevent migraine headaches, but other studies do not. Even though not all studies agree, several professional societies recommend trying riboflavin because it might be effective and has few side effects. The Canadian Headache Society, for example, recommends 400 milligrams (mg)/day of riboflavin, under the guidance of a health care provider, for preventing migraines. This is a very large daily dose, so we advise talking with your health care provider about riboflavin and migraines to find out what’s best for you.

Q. Can zinc make your hair grow?

A. Like all vitamins and minerals, it’s important to get enough zinc for good health. In most cases, hair loss is hereditary and is not related to the amount of zinc you consume. But it is true that a zinc deficiency can cause hair loss in otherwise healthy individuals. If you have a zinc deficiency, increasing your zinc intake to correct the deficiency should help. But this doesn’t mean that taking extra zinc will make your hair thicker or longer.

Most people in the United States get enough zinc from the foods they eat, about 8 to 11 milligrams (mg) per day for adults. You can get the recommended amount by eating a variety of foods, including red meat, poultry, oysters and other seafood, beans, nuts, whole grains, and dairy products.

Getting too much zinc—more than 40 mg per day for adults—can cause problems such as nausea, vomiting, and low copper levels. So, the bottom line is, make sure you’re getting enough zinc but not too much.

Q. What does the Supplement Facts label on a dietary supplement tell me?

A. All products labeled as dietary supplements carry a Supplement Facts label that is similar to the Nutrition Facts label found on food products. It lists the active ingredients and their amounts, plus other added ingredients like fillers, binders, and flavorings. It also gives a suggested serving size, but you and your health care provider might decide that a different amount is more appropriate for you.

In the Supplement Facts label, the amounts of vitamins, minerals, and other nutrients like dietary fiber are listed as a percentage of the Daily Value (%DV). Each nutrient has one DV that applies to all people aged 4 and older. For example, the DV for vitamin C is 90 milligrams (mg) and the DV for the B-vitamin biotin is 30 micrograms (mcg).

The %DV allows you to see how much a product contributes to your approximate daily needs for that nutrient. For example, if a supplement provides 50% of the DV for calcium, it contributes about half of your daily needs for calcium.

Q. When did the new Supplement Facts labels come out and how do they differ from the old labels?

A. Some manufacturers have been using the new labels for several years, but others didn’t start using them until 2021. Here is a look at the new Supplement Facts label for a multivitamin supplement:

Key changes include:

• Listing vitamin D in micrograms (mcg) instead of international units (IU), although manufacturers can also list IU in parentheses. The units for other nutrients, including vitamin E, vitamin A, and folate, have also changed.
• New or updated DVs for many nutrients, including 30 mcg for biotin, 90 milligrams (mg) for vitamin C (instead of 60 mg), and 2.4 mcg for vitamin B12 (instead of 6.0 mcg).

Q. I have been taking a vitamin D supplement that contains 400 IU, which is 100% of the DV. I just purchased another vitamin D supplement that also contains 400 IU, but its label says it provides only 50% of the DV. How can that be?

A. There is a simple explanation—the supplement you are currently using has the old Supplement Facts label, and the one you just purchased has the new label. For many years, the DV for vitamin D was 400 IU. Therefore, a vitamin D supplement containing 400 IU would provide 100% of the DV.

However, research shows that many adults need somewhat more vitamin D than previously thought. So, the FDA increased the DV for vitamin D and also changed the units.

The new DV is 20 mcg (micrograms), which is equal to 800 IU. Because the DV has changed, a 400 IU vitamin D supplement bearing the new Supplement Facts label provides only half, or 50%, of the DV.

On the new label, manufacturers must list the amount of vitamin D in mcg, but they can also list it in IU to make the transition a little less confusing for consumers.

Q. My cardiologist recommended a 100 IU supplement of natural vitamin E. I found a supplement that has 100 mg of vitamin E. is that the same as 100 IU?

A. No, 100 milligrams (mg) of vitamin E is not the same as 100 International Units (IU); the units make a difference.

The amount that your cardiologist recommended—100 IU of natural vitamin E—is equal to 67 mg of vitamin E. This is because 1 IU of natural vitamin E is equal to 0.67 mg of vitamin E.

As you noticed, vitamin E is labeled in mg on the new Supplement Facts label instead of IU. It now matches the units used for vitamin E’s recommended intake, which is 15 mg for most adults.

Many people take dietary supplements in an effort to be well and stay healthy. Herbal medicines or botanicals, also called “natural products,” are one type of dietary supplement. Dietary supplements can come in the form of pills, powders, or liquids and are widely available. While there is a lot of evidence that dietary supplements help in preventing and treating nutrient deficiency, there is much less evidence about their usefulness in preventing or treating other diseases. So, there is a lot we don’t know.

If you are thinking about or are using a dietary supplement, here are five tips to consider.

1. Take charge of your health by being an informed consumer. The standards for marketing supplements are very different from the standards for drugs. For example, marketers of a supplement do not have to prove to the Food and Drug Administration that it is safe or that it works before it arrives on grocery store shelves. Find out what the scientific evidence says about the safety of a dietary supplement and whether it works. The resources below can help you.
2. “Natural” does not necessarily mean “safe.” For example, the herbs comfrey and kava can cause serious harm to the liver. Also, when you see the term “standardized” (or “verified” or “certified”) on the bottle, it does not necessarily guarantee product quality or consistency.
3. Interactions are possible. Some dietary supplements may interact with medications (prescription or over-the-counter) or other dietary supplements, and some may have side effects on their own. Research has shown that St. John’s wort interacts with many medications in ways that can interfere with their intended effects, including antidepressants, birth control pills, antiretrovirals used to treat HIV infection, and others.
4. Be aware of the potential for contamination. Some supplements have been found to contain hidden prescription drugs or other compounds, particularly in dietary supplements marketed for weight loss, sexual health including erectile dysfunction, and athletic performance or body-building.
5. Talk to your health care providers. Tell your health care providers about any complementary health products or practices you use, including dietary supplements. This will help give them a full picture of what you are doing to manage your health and will help ensure coordinated and safe care.